Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Using Direct Analysis of Bioreactor Harvest for Clone Selection and Process Optimization Therapeutic monoclonal antibodies (MAbs) mostly are manufactured using bioengineered mammalian cells cultured in a bioreactor for two to three weeks. High temperatures and an altered redox environment may compromise the quality of MAbs produced (e.g., fragmentation, truncation), as can the presence of proteases, reductases, and other chemicals released from dead cells. Thus, it would be valuable to establish analytical methods that can help cell culture groups monitor immunoglobulin…

This webinar features: Esha Vyas, Field Applications Manager, Asahi Kasei Bioprocess America Virus filtration is a critical unit operation in the manufacture of biotherapeutic products. Rigorous and careful validation of this process-dependent step is necessary to demonstrate that the selected virus filter meets regulatory requirements. Thoughtful design and implementation of spiking studies are imperative to successful validation, and these studies may include consideration of various robustness and process parameters. Overall, the study design should be conducted as a representative scaled-down…

Protein A has made monoclonal antibodies (MAbs) highly manufacturable and easier to develop in laboratories. Its use has enabled purification platform approaches, which have been key elements in growth of the MAb market. But in general, protein A columns are too large, which means they either limit the use of prepacked technology, or create a mismatch between a protein A column and downstream operations. Protein A columns also are more prone to bioburden contamination than any other step in a…

Lonza will establish Centers of Excellence for Cell and Gene Therapy to support and accelerate the growth of this priority area for the company. This decision advances Lonza’s strategy of being one of the world’s leading, integrated, value-added solutions providers along the healthcare continuum. To further improve its support to customers, Lonza’s Cell- and Gene-Therapy Centers of Excellence will include Lonza sites that are already serving customers and their patients with these innovative technologies. The Lonza sites in Pearland, TX…